510(k) K942639

BIOPSY NEEDLE AND HOUSING by Biopsys Medical, Inc. — Product Code KNW

K942639 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "BIOPSY NEEDLE AND HOUSING". The FDA issued a decision of Substantially Equivalent on July 7, 1994. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Biopsys Medical, Inc. has at least 10 other 510(k) clearances on record.